Critically Ill PatientsNCT07025941
Impact of Comprehensive Rehabilitation Nursing Combined With Refined Airway Management and Nutritional Support on Prognosis and Care Delivery Models in Critically Ill Patients
A study testing Standard Critical Care Nursing Protocol and ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes) in people with Critically Ill Patients and Nutritional Support, run by Taizhou Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This combined intervention protocol effectively improves the prognosis of critically ill patients and optimizes nursing management models Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critically Ill Patients, Nutritional Support, Pulmonary Infections
- What is being tested?
- Standard Critical Care Nursing Protocol and ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2023to 23 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfillment of ICU admission standards with critical illness confirmed by attending physicians or senior specialists
- Age ≥ 18 years
- Stable vital signs:
- Systolic blood pressure ≥ 90 mmHg and ≤ 180 mmHg
- Heart rate ≤ 120 beats/min
- Oxygen saturation (SpO₂) ≥ 85% under ≤ 60% fraction of inspired oxygen (FiO₂)
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- Intact or tolerable gastrointestinal (GI) function for enteral nutrition
- Informed consent from both patients and families Exclusion Criteria:(1)
- Terminal malignancies
- Brain death
- Irreversible organ failure (e.g., end-stage cirrhosis, advanced heart failure)
- Comorbidities potentially confounding study outcomes
- Contraindications to interventions (e.g., laryngeal edema, complete intestinal obstruction)
- Pregnancy or lactation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Taizhou Hospital of Traditional Chinese Medicine
Taizhou, Jiangsu, 225300
About this study
This combined intervention protocol effectively improves the prognosis of critically ill patients and optimizes nursing management models
Read the detailed description
To investigate the impact of comprehensive rehabilitation nursing combined with refined airway management and nutritional support on the prognosis of critically ill patients and nursing management models, and to develop a new care management protocol. Critically ill patients were divided into a control group (routine nursing) and an intervention group (comprehensive rehabilitation nursing combined with refined airway management and nutritional support). Complications such as pulmonary infection and gastrointestinal bleeding, as well as clinical indicators including oxygen saturation (SpO₂), mechanical ventilation time (MVT), and length of stay (LOS), were compared between the two groups. Logistic regression and XGBoost models were constructed to analyze key influencing factors.
- Conditions
- Critically Ill Patients, Nutritional Support, Pulmonary Infections, Gastrointestinal Bleeding, Acute Kidney Injury (AKI)
- Being tested
- Standard Critical Care Nursing Protocol, ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes)
- Medical subject headings
- Gastrointestinal Hemorrhage, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Critical Care Nursing ProtocolOther
The Standard Critical Care Nursing Protocol encompasses evidence-based, routine nursing practices for critically ill patients in the intensive care unit (ICU). This protocol serves as the control intervention in comparative studies evaluating novel nursing strategies.
Key Components:
Basic Physiological Monitoring:
Continuous assessment of vital signs (heart rate, blood pressure, respiratory rate, SpO₂).
Strict intake/output monitoring and electrolyte balance management.
Airway Management:
Standard oxygen therapy (nasal cannula, face mask) or mechanical ventilation as prescribed.
Scheduled suctioning, positional changes, and oral care (every 4-6 hours).
Infection Prevention:
Aseptic techniques for invasive procedures (e.g., central line care, urinary catheter management).
Ventilator-associated pneumonia (VAP) bundle compliance (e.g., head-of-bed elevation, sedation vacations).
Mobility \& Skin Integrity:
Passive range-of-motion exercises for immobilized patients (2×/day).
Pr
ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes)Behavioural
The intervention group received a standardized 14-day nursing protocol combining three evidence-based components:
Comprehensive Rehabilitation Nursing:
Early mobilization protocol with passive/active exercises (3-4 sessions/day)
Respiratory training using incentive spirometry (Triflo II® devices)
Swallowing rehabilitation with VitalStim® electrical stimulation
Refined Airway Management:
Humidification via Fisher \& Paykel® MR850 systems (33-44 mg/L)
Closed suction systems (Ballard® Trach Care) with strict aseptic technique
Oral care with 0.12% chlorhexidine solution (Peridex®) 4×/day
Nutritional Support:
Enteral feeding using Abbott Nutrition® formulas
Parenteral nutrition via Baxter®/Fresenius Kabi® solutions
Gastric residual monitoring with Kangaroo™ feeding pumps
Key Features:
Implemented by specialized ICU nurses, respiratory therapists, and dietitians
Daily monitoring using Philips® IntelliVue patient monitors
Protocol adjustments based on weekly APACHE II scoring
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Not described Receives: Other: Standard Critical Care Nursing Protocol |
| intervention group | Experimental | Not described Receives: Behavioral: ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay (LOS)
Calendar days from ICU admission to discharge criteria met (APACHE II score ≤10, hemodynamic stability for ≥24h).
Measured: From randomization to ICU discharge, up to 60 days
Secondary outcomes (1)
Incidence of Pulmonary Infections
Rate of ventilator-associated pneumonia (VAP) and other pulmonary infections confirmed by clinical criteria (temperature >38°C or <36°C, purulent secretions, leukocytosis >10×10⁹/L or leukopenia <4×10⁹/L) plus microbiological evidence from sputum/BALF cultures.
Measured: From ICU admission to 48 hours post-extubation or 14-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start2 Jun 2023
- Primary completion5 Jun 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital of Traditional Chinese Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Peibei zhang, Taizhou Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025941
- Sponsor's protocol ID
- 20240511
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Comprehensive Rehabilitation Nursing Combined With Refined Airway Management and Nutritional Support on Prognosis and Care Delivery Models in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07025941
- Acronym / sponsor ID
- 20240511
- Conditions
- Critically Ill Patients, Nutritional Support, Pulmonary Infections, Gastrointestinal Bleeding, Acute Kidney Injury (AKI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Taizhou Hospital of Traditional Chinese MedicineOther government
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This combined intervention protocol effectively improves the prognosis of critically ill patients and optimizes nursing management models
Detailed description
To investigate the impact of comprehensive rehabilitation nursing combined with refined airway management and nutritional support on the prognosis of critically ill patients and nursing management models, and to develop a new care management protocol. Critically ill patients were divided into a control group (routine nursing) and an intervention group (comprehensive rehabilitation nursing combined with refined airway management and nutritional support). Complications such as pulmonary infection and gastrointestinal bleeding, as well as clinical indicators including oxygen saturation (SpO₂), mechanical ventilation time (MVT), and length of stay (LOS), were compared between the two groups. Logistic regression and XGBoost models were constructed to analyze key influencing factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Standard Critical Care Nursing Protocol |
| intervention group | Experimental | Behavioral: ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Fulfillment of ICU admission standards with critical illness confirmed by attending physicians or senior specialists
- Age ≥ 18 years
- Stable vital signs:
- Systolic blood pressure ≥ 90 mmHg and ≤ 180 mmHg
- Heart rate ≤ 120 beats/min
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Critical Care Nursing ProtocolThe Standard Critical Care Nursing Protocol encompasses evidence-based, routine nursing practices for critically ill patients in the intensive care unit (ICU). This protocol serves as the control intervention in comparative studies evaluating novel nursing strategies. Key Components: Basic Physiological Monitoring: Continuous assessment of vital signs (heart rate, blood pressure, respiratory rate, SpO₂). Strict intake/output monitoring and electrolyte balance management. Airway Management: Standard oxygen therapy (nasal cannula, face mask) or mechanical ventilation as prescribed. Scheduled suctioning, positional changes, and oral care (every 4-6 hours). Infection Prevention: Aseptic techniques for invasive procedures (e.g., central line care, urinary catheter management). Ventilator-associated pneumonia (VAP) bundle compliance (e.g., head-of-bed elevation, sedation vacations). Mobility \& Skin Integrity: Passive range-of-motion exercises for immobilized patients (2×/day). Pr | Other | control group |
| ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes)The intervention group received a standardized 14-day nursing protocol combining three evidence-based components: Comprehensive Rehabilitation Nursing: Early mobilization protocol with passive/active exercises (3-4 sessions/day) Respiratory training using incentive spirometry (Triflo II® devices) Swallowing rehabilitation with VitalStim® electrical stimulation Refined Airway Management: Humidification via Fisher \& Paykel® MR850 systems (33-44 mg/L) Closed suction systems (Ballard® Trach Care) with strict aseptic technique Oral care with 0.12% chlorhexidine solution (Peridex®) 4×/day Nutritional Support: Enteral feeding using Abbott Nutrition® formulas Parenteral nutrition via Baxter®/Fresenius Kabi® solutions Gastric residual monitoring with Kangaroo™ feeding pumps Key Features: Implemented by specialized ICU nurses, respiratory therapists, and dietitians Daily monitoring using Philips® IntelliVue patient monitors Protocol adjustments based on weekly APACHE II scoring | Behavioural | intervention group |
Primary outcome
ICU Length of Stay (LOS)
Time frame: From randomization to ICU discharge, up to 60 days
Calendar days from ICU admission to discharge criteria met (APACHE II score ≤10, hemodynamic stability for ≥24h).
1 secondary outcome
Incidence of Pulmonary Infections
Time frame: From ICU admission to 48 hours post-extubation or 14-day intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Critical Care Nursing Protocol and ICU-PRO Nursing Protocol (Integrated Critical Care Protocol for Rehabilitation Outcomes) in people with Critically Ill Patients and Nutritional Support, run by Taizhou Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (LOS) (time frame: From randomization to ICU discharge, up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.